CMS Pub. 100-18, ch. 6, § 30.3.4.4

When a Part D sponsor notifies CMS of a formulary change in HPMS, the change is assigned a

prospective effective date. During the period of time between when a Part D sponsor has

notified CMS of a prospective change and the actual effective date of that change, Part D

sponsors must ensure appropriate beneficiary protections are implemented should a beneficiary

who has not been notified of the change present with a new prescription for the drug whose

formulary status is changing.

For maintenance changes outlined in section 30.3.3.2, the Part D sponsor must implement the

beneficiary notice requirements contained in section 30.3.4.1 (i.e., 60 days of advance written

notice before implementing the change for the individual). For example, assume on March 1st, a

Part D sponsor notifies CMS via HPMS that it is removing a brand name drug from its formulary

due to the availability of a new generic. The sponsor indicates the effective date for this

formulary change will be May 1st. If a beneficiary were to present on April 1st with a new

prescription for the brand name drug pending removal, the Part D sponsor would provide written

notice of the change and not implement the change until June 1st, in order to provide the full 60

days of advance notice to that beneficiary.

A Part D sponsor may elect to provide written notice to all of its enrollees of a pending

formulary maintenance change in lieu of notifying only the “affected enrollees.” Such an

approach would satisfy the beneficiary notice requirements in section 30.3.4.1 because all

enrollees, including “affected enrollees” would receive advance notice of a formulary change. In

addition, it would preclude the plan from needing to extend the formulary change effective date

for those enrollees who present with a new prescription for the drug between the date when a

Part D sponsor notifies CMS of a prospective change and the actual effective date of that change.

However, Part D sponsors are still required to provide advance written notice of a formulary

change and a 60 day-supply of the drug whose formulary status is changing to those beneficiaries

who enroll in the plan after the initial advance formulary change notice, as described above.

For non-maintenance changes outlined in section 30.3.3.3, the Part D sponsors must not

implement the formulary change for a beneficiary who presents with a new prescription for a

pending formulary drug. In accordance with our non-maintenance formulary change policy,

enrollees currently taking the affected drug must be exempt from the formulary change for the

remainder of the contract year. For example, assume on March 1st, a Part D sponsor notifies

CMS via HPMS it is removing a drug from its formulary with no replacement. CMS approves

the change. The sponsor indicates the effective date for this formulary change will be May 1st.

If a beneficiary were to present on April 1st with a new prescription for the drug pending

removal, the Part D sponsor would not implement this change for the beneficiary for the

remainder of the contract year.